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Secretary's Advisory Committee on Human Research Protections (SACHRP)
SACHRP July 31 – August 1, 2006 Meeting Presentations
July 31, 2006 – Presentations
Adverse Event Reporting in Clinical Research: Update on New Coordinated Federal Policy Initiative
By: Amy Patterson, M.D., NIH OHRP’s Draft Guidance on Reporting and Reviewing Adverse Events and Unanticipated Problems
By: Michael Carome, M.D., CAPT, U.S. Public Health Service, OHRP Subpart A Subcommittee (SAS) Update
By: Felix Gyi, Pharm.D, M.B.A., CIP, and Daniel K. Nelson, M.S., CIP 10th Report for SACHRP Consideration Clarifying 45 CFR Subpart D Definitions
By: Celia B. Fisher, Ph.D., and Susan Z. Kornetsky, M.P.H.
August 1, 2006 - Presentations
Ethical Considerations for Research Involving Prisoners Overview (IOM Report)
By: Wendy Visscher, Ph.D. Introduction: Decisional Impairment and Vulnerability
By: David H. Strauss, M.D. Overview of the History of Proposed Regulations for the Institutionalized Mentally Disturbed
By: Charles R. Mackay, Ph.D. Impaired Decision-Making Capacity and Recent Ethics Panel
Recommendations: Additional Safeguards and Restrictions on Translational Research
By: David Shore, M.D. Research with Decisionally-Impaired Individuals: A Family Perspective
By: Laurie Flynn, Director, Carmel Hill Center, Columbia University Protecting Research Subjects with Diminished Capacity
By: Myra J. Christopher, President and CEO, Center for Practical Bioethics IRB Considerations and Wrap Up
By: David H. Strauss, M.D.
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